Effect of Pressure Support vs Unassisted
Breathing Through a Tracheostomy
Collar on Weaning Duration in Patients
Requiring Prolonged Mechanical
VentilationA Randomized Trial
Amal Jubran, MD; Brydon J. B. Grant, MD; Lisa A. Duffner, BS; Eileen G. Collins, RN, PhD;
Dorothy M. Lanuza, RN, PhD; Leslie A. Hoffman, RN, PhD; Martin J. Tobin, MD
Importance Patients requiring prolonged mechanical ventilation (>21 days) are
commonly weaned at long-term acute care hospitals (LTACHs). The most effective
method of weaning such patients has not been investigated.
Objective To compare weaning duration with pressure support vs unassisted breathing
through a tracheostomy collar in patients transferred to an LTACH for weaning from
prolonged ventilation.
Design, Setting, and Participants Between 2000 and 2010, a randomized study was
conducted in tracheotomized patients transferred to a single LTACH for weaning from
prolonged ventilation. Of 500 patients who underwent a 5-day screening procedure, 316
did not tolerate the procedure and were randomly assigned to receive weaning with
pressure support (n = 155) or a tracheostomy collar (n = 161). Survival at 6- and 12month time points was also determined.
Main Outcome Measure Primary outcome was weaning duration. Secondary outcome
was survival at 6 and 12 months after enrollment.
Results Of 316 patients, 4 were withdrawn and not included in analysis. Of 152
patients in the pressure-support group, 68 (44.7%) were weaned; 22 (14.5%) died. Of
160 patients in the tracheostomy collar group, 85 (53.1%) were weaned; 16 (10.0%)
died. Median weaning time was shorter with tracheostomy collar use (15 days;
interquartile range [IQR], 8-25) than with pressure support (19 days; IQR, 1231), P = .004. The hazard ratio (HR) for successful weaning rate was higher with
tracheostomy collar use than with pressure support (HR, 1.43; 95% CI, 1.031.98; P = .033) after adjusting for baseline clinical covariates. Use of the tracheostomy
collar achieved faster weaning than did pressure support among patients who did not
tolerate the screening procedure between 12 and 120 hours (HR, 3.33; 95% CI, 1.447.70; P = .005), whereas weaning time was equivalent with the 2 methods in patients
who did not tolerate the screening procedure within 0 to 12 hours. Mortality was
equivalent in the pressure-support and tracheostomy collar groups at 6 months (55.92%
vs 51.25%; 4.67% difference, 95% CI, −6.4% to 15.7%) and at 12 months (66.45% vs
60.00%; 6.45% difference, 95% CI, −4.2% to 17.1%).
Conclusion and Relevance Among patients requiring prolonged mechanical
ventilation and treated at a single long-term care facility, unassisted breathing through a
tracheostomy, compared with pressure support, resulted in shorter median weaning
time, although weaning mode had no effect on survival at 6 and 12 months.
Association of Hydroxyethyl Starch Administration With Mortality and Acute
Kidney Injury in Critically Ill Patients Requiring Volume ResuscitationA
Systematic Review and Meta-analysis
Ryan Zarychanski, MD, MSc; Ahmed M. Abou-Setta, MD, PhD; Alexis F. Turgeon,
MD, MSc; Brett L. Houston, BSc; Lauralyn McIntyre, MD, MSc; John C. Marshall,
MD; Dean A. Fergusson, PhD, MHA
JAMA. 2013;309(7):678-688. doi:10.1001/jama.2013.430.
Importance Hydroxyethyl starch is commonly used for volume resuscitation yet has
been associated with serious adverse events, including acute kidney injury and death.
Clinical trials of hydroxyethyl starch are conflicting. Moreover, multiple trials from one
investigator have been retracted because of scientific misconduct.
Objectives To evaluate the association of hydroxyethyl starch use with mortality and
acute kidney injury.
Data Sources Randomized controlled trials from MEDLINE, EMBASE, CENTRAL,
Global Health, HealthStar, Scopus, Web of Science, the International Clinical Trials
Registry Platform (inception to October 2012), reference lists of relevant articles, and
gray literature.
Study Selection Two reviewers independently identified randomized controlled trials
comparing hydroxyethyl starch with other resuscitation fluids in critically ill patients
receiving acute volume resuscitation.
Data Extraction Two reviewers independently extracted trial-level data including
population characteristics, interventions, outcomes, and funding sources. Risk of bias
was assessed using the risk of bias tool; the strength of evidence was adjudicated using
the GRADE methodology.
Results We included 38 eligible trials comparing hydroxyethyl starch to crystalloids,
albumin, or gelatin. The majority of trials were categorized as having an unclear risk or
high risk of bias. For the 10 880 patients in studies contributing mortality data, the risk
ratio (RR) for death among patients randomized to receive hydroxyethyl starch was 1.07
(95% CI, 1.00 to 1.14; I2, 0%; absolute risk [AR], 1.20%; 95% CI, −0.26% to 2.66%).
This summary effect measure included results from 7 trials performed by an
investigator whose subsequent research had been retracted because of scientific
misconduct. When we excluded these 7 trials that involved 590 patients, hydroxyethyl
starch was found to be associated with increased mortality among 10 290 patients (RR,
1.09; 95% CI, 1.02 to 1.17; I2, 0%; AR, 1.51%; 95% CI, 0.02% to 3.00%), increased
renal failure among 8725 patients (RR, 1.27; 95% CI, 1.09 to 1.47; I2, 26%; AR, 5.45%;
95% CI, 0.44% to 10.47%), and increased use of renal replacement therapy among 9258
patients (RR, 1.32; 95% CI, 1.15 to 1.50; I2, 0%; AR, 3.12%; 95% CI, 0.47% to 5.78%).
Conclusion and Relevance In critically ill patients requiring acute volume
resuscitation, use of hydroxyethyl starch compared with other resuscitation solutions
was not associated with a decrease in mortality. Moreover, after exclusion of 7 trials
performed by an investigator whose research has been retracted because of scientific
misconduct, hydroxyethyl starch was associated with a significant increased risk of
mortality and acute kidney injury. Clinical use of hydroxyethyl starch for acute volume
resuscitation is not warranted due to serious safety concern